Treatment for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
University Health Network, Toronto, Canada
+1 More
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response.

See full description

Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 3 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 6 years.

6 years
Complete Pathologic Response (pCR)
Generic Quality of Life (QoL)
Pain level assessment
Pathological Minimal Residual Disease (pMRD)
Quality of Life-Prostate Cancer Patients

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

6 Treatment Groups

Group 3

This trial requires 315 total participants across 6 different treatment groups

This trial involves 6 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Group 3LHRHa plus abiraterone acetate plus prednisone plus niraparib
Group 1bLHRHa plus apalutamide plus abiraterone acetate plus prednisone.
Group 4LHRHa plus apalutamide plus atezolizumab
Group 1a
Drug
LHRHa plus apalutamide.
Group 2aLHRHa plus abiraterone acetate plus prednisone.
Group 2bLHRHa plus abiraterone acetate plus prednisone plus docetaxel.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 years for reporting.

Who is running the study

Principal Investigator
M. G.
Martin Gleave, Principal Investigator/Study Chair
University of British Columbia

Closest Location

University Health Network - Toronto, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who want to participate in the master protocol must have good end-organ function and all laboratory tests must be done within the last 4 weeks. show original
Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate show original
A prostate cancer diagnosis is made when a patient has a PSA level of 20 or more, and a Gleason score of 4 or greater in at least 50% of the sampled cores, or a Gleason score of 5 or greater in at least 25% of the sampled cores. show original
A patient's Gleason score is 8 or greater on a minimum of one core, either targeted or systematic biopsy, and their PSA level is 20 or greater. show original
- I. Males ≥ 18 years of age
This is a statement about a type of prostate cancer show original
Participants with oligometastatic (< 3) metastases by PSMA (Prostate-Specific Membrane Antigen) imaging only who are deemed candidates for radical prostatectomy are eligible
Participants must agree to genetic testing when they register and before they are assigned to a central reference laboratory. show original
No prior systemic or localized treatment is necessary for prostate cancer show original
The individual has a life expectancy of 3 years or more and has a performance status of 0 or 1 according to the ECOG scale. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for prostate cancer?

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In the United States, the vast majority of men diagnosed with prostate cancer are treated with androgen blockers or surgery. Additionally, a wide variety of other treatments for prostate cancer are used.

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How many people get prostate cancer a year in the United States?

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About 0.6 million men experience [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) a year in the United States. This puts them right at the top of the list of cancer diagnoses in the United States.

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What causes prostate cancer?

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Prostate cancer can be attributed to a complex array of genetic and environmental stimuli. If tumors in the prostate are to be diagnosed, it is important to establish whether they are prostate cancer or a benign prostate hyperplasia.

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What are the signs of prostate cancer?

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The most sensitive and specific initial sign of prostate cancer is elevated blood PSA level. Although most of the men with clinically insignificant prostate cancer will not have any prostate cancer-related symptoms or complaints, a small percentage will develop symptoms that are suggestive of prostate cancer. The most important symptom is difficulty in urinating with a concurrent low urinary flow rate and pain in the lower back.

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Can prostate cancer be cured?

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Prostatic carcinoma in young men is treated mainly via radical surgical therapy. Most patients succumb to localised disease which remains asymptomatic. The authors advocate radical surgical intervention with pelvic lymphadenectomy and/or salvage radiation therapy following a positive pelvic examination when radical surgery fails to cure the illness.

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What is prostate cancer?

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Prostate cancer is a cancer that arises in the prostate gland in males. While prostate cancer is uncommon in younger men, it becomes more common as men get older. In men who are diagnosed with prostate cancer, the cancer can be removed surgically with positive margins. However, in most cases, prostate cancer will not be cured after surgery. This is due to the number of risk factors associated with this condition. Most men with prostate cancer can expect to live for at least 10 years (75% of the time) after they receive the first treatment because they may develop an aggressive form of the condition. Although survival rates vary widely between individuals, it is important to understand the risks and benefits of different treatment options before making the best choice.

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What is the survival rate for prostate cancer?

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Although the survival rate for prostate cancer varies based on the Gleason scoring system used it remains about 98% to 99% depending upon the stage of the disease.

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Does treatment improve quality of life for those with prostate cancer?

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Active treatment for prostate cancer can provide significant improvements in the quality of life of treated patients. Moreover, the psychological and physical aspects of the prostate cancer treatment are important to consider when designing and evaluating treatment plans and programs.

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Have there been other clinical trials involving treatment?

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The study of alternative treatments of this disease is needed; moreover, the development of new treatment algorithms is necessary to optimize the use of available drugs.

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What are the common side effects of treatment?

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Although most side effects occurring with current treatments for prostate cancer have a low frequency it is important to consider that some side effects may be irreversible, as a result of the androgen deprivation therapy.

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How serious can prostate cancer be?

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PSA levels are better than Gleason scores at predicting survival outcomes in [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). They are independent indicators of how far and in what direction the disease has spread. The prognosis of prostate cancer is far worse if the cancer appears to be only locally advanced and limited to the prostate with no evidence of the presence of systemic metastasis. In this group, survival following initial treatment is better. Overall survival averages 10 to 15 years following diagnosis in patients who have had radical prostatectomy even with the most aggressive disease. The disease can persist without treatment but it's still curable.

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What does treatment usually treat?

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Inappropriate overuse or underuse of radiotherapy may have an impact on the patients health status. We emphasize the importance that the patients should not suffer from the side effects of external beam radiation therapy or the increased costs of radiotherapy. As a guideline, physicians should consider an individual patient's preferences and expectations. We advise our patients to have a discussion about the benefits and risks of radiotherapy with their doctors.

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